WO2020256865A1 - Dispositifs de collecte de fluide comprenant une zone de fixation de base, et systèmes et procédés associés - Google Patents

Dispositifs de collecte de fluide comprenant une zone de fixation de base, et systèmes et procédés associés Download PDF

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Publication number
WO2020256865A1
WO2020256865A1 PCT/US2020/033064 US2020033064W WO2020256865A1 WO 2020256865 A1 WO2020256865 A1 WO 2020256865A1 US 2020033064 W US2020033064 W US 2020033064W WO 2020256865 A1 WO2020256865 A1 WO 2020256865A1
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WO
WIPO (PCT)
Prior art keywords
fluid
mold
end region
oil
barrier
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2020/033064
Other languages
English (en)
Inventor
Ashley Marie JOHANNES
Hollie TRULLENQUE
Eric Rehm
Michelle ROOT
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
PureWick Corp
Original Assignee
PureWick Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by PureWick Corp filed Critical PureWick Corp
Priority to CA3143904A priority Critical patent/CA3143904C/fr
Priority to US17/596,629 priority patent/US12419778B2/en
Priority to EP20730518.6A priority patent/EP3986344B1/fr
Priority to JP2021576074A priority patent/JP7502347B2/ja
Priority to CN202080057663.0A priority patent/CN114502115B/zh
Publication of WO2020256865A1 publication Critical patent/WO2020256865A1/fr
Anticipated expiration legal-status Critical
Priority to US19/310,118 priority patent/US20260047956A1/en
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/451—Genital or anal receptacles
    • A61F5/455—Genital or anal receptacles for collecting urine or discharge from female member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/4404—Details or parts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D22/00—Producing hollow articles
    • B29D22/003—Containers for packaging, storing or transporting, e.g. bottles, jars, cans, barrels, tanks
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2021/00—Use of unspecified rubbers as moulding material
    • B29K2021/003—Thermoplastic elastomers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2083/00—Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material

Definitions

  • FLUID COLLECTION DEVICES INCLUDING A BASE SECUREMENT AREA, AND RELATED SYSTEMS AND METHODS
  • An individual may have limited or impaired mobility such that typical urination processes are challenging or impossible.
  • the individual may have surgery or a disability that impairs mobility.
  • the individual may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, fluid collection from the individual may be needed for monitoring purposes or clinical testing.
  • Bed pans and urinary catheters such as a Foley catheter, may be used to address some of these circumstances.
  • bed pans and urinary catheters have several problems associated therewith.
  • bed pans may be prone to discomfort, pressure ulcers spills, and other hygiene issues.
  • Urinary catheters be may be uncomfortable, painful, and may cause urinary tract infections.
  • a fluid collection device includes a fluid impermeable barrier and a fluid permeable body.
  • the fluid impermeable barrier has an inner surface at least partially defining a chamber, a first end region defining an aperture extending therethrough and including a first outer surface portion, and a second end region distal to the first end region and including a second outer surface portion having more adhesive strength than the first outer surface portion.
  • the fluid impermeable barrier also defines an opening extending longitudinally along the fluid impermeable barrier and configured to be positioned adjacent to a female urethra.
  • the fluid permeable body is positioned at least partially within the chamber to extend across at least a portion of the opening and configured to wick fluid away from the opening.
  • a fluid collection device includes a fluid impermeable barrier and a fluid permeable body.
  • the fluid impermeable barrier at least partially defines a chamber, an opening extending longitudinally along the fluid impermeable barrier and configured to be positioned adjacent to a female urethra, and an aperture extending therethrough.
  • At least a portion of the fluid impermeable barrier has a composition including oil and at least one of silicone or thermoplastic elastomer (TPE), the composition including about 60 oil parts per hundred rubber (phr) to about 200 oil phr based on 100 phr of styrene block co-polymer.
  • TPE thermoplastic elastomer
  • the fluid permeable body is positioned at least partially within the chamber to extend across at least a portion of the opening and configured to wick fluid away from the opening.
  • a method of forming a fluid impermeable barrier of a fluid collection device includes inserting a composition including at least one of silicone or TPE into a barrier mold.
  • the barrier mold includes a first mold portion having a first mold surface and a second portion having a second mold surface more polished than the first mold surface.
  • the method also includes molding the composition in the barrier mold to form a fluid impermeable barrier having an inner surface at least partially defining a chamber, a first end region having a first outer surface portion interfacing the first mold surface, a second end region distal to the first end region and having a second outer surface portion interfacing the second mold surface, and an opening extending longitudinally along the fluid impermeable barrier.
  • the opening is configured to be positioned adjacent to a female urethra, and the second outer surface portion has more adhesive strength than the first outer surface portion.
  • a method of forming a fluid impermeable barrier of a fluid collection device includes inserting a composition into at least a portion of a barrier mold, the composition including at least one of silicone or TPE and about 60 oil phr to about 200 oil phr based on 100 phr of styrene block co-polymer.
  • the method also includes molding the composition in the barrier mold to form at least a portion of a fluid impermeable barrier defining a chamber and an opening extending therethrough, the opening configured to be positioned adjacent to a female urethra.
  • the method also includes removing the fluid impermeable barrier from the barrier mold.
  • FIG. 1A is an isometric view of a female fluid collection device, according to an embodiment.
  • FIG. IB is a front view of the female fluid collection device of FIG. 1A worn on a female user.
  • FIG. 1C is an exploded view of the female fluid collection device of FIG. 1A.
  • FIGS. 2A and 2B are cross-sectional views of the female fluid collection device of FIG. 1A taken along line 2-2 thereof, according to various embodiments.
  • FIG. 3A is an isometric front view of a female fluid collection device, according to a second embodiment.
  • FIG. 3B is an exploded view of the female fluid collection device of FIG. 3A.
  • FIG. 3C is a rear isometric view of the female collection device of FIG. 3A.
  • FIG. 4 is a flow diagram of a method of forming a fluid impermeable barrier of a fluid collection device.
  • FIG. 5 is a flow diagram of a method of assembling a fluid collection device, according to an embodiment.
  • FIG. 6 is a flow diagram of a method to collect fluid, according to an embodiment.
  • FIG. 7 is a block diagram of a system for fluid collection, according to an embodiment.
  • Embodiments disclosed herein include fluid collection devices and methods of forming fluid collection devices.
  • fluid collection devices perform better when a portion of the fluid impermeable barrier is positioned at least partially within the gluteal cleft of the wearer.
  • the fluid impermeable barrier of conventional fluid collection devices may slip from between the gluteal cleft, thus rendering the fluid collection device less effective.
  • One or more embodiments of fluid collection devices described herein include a base securement area having an improved outer surface that promote improved adhesion between at least a portion of the fluid impermeable barrier and the gluteal cleft.
  • fluid collection devices described herein also include fluid impermeable barriers having a longer longitudinal length, further promoting adhesion of the fluid collection device at least partially within the gluteal cleft of larger or obese users. Exemplary fluid collection devices for use with the systems and methods herein are described in more detail below.
  • a fluid collection device includes a fluid impermeable barrier and a fluid permeable body.
  • the fluid impermeable barrier has an inner surface at least partially defining a chamber, a first end region defining an aperture extending therethrough and including a first outer surface portion, and a second end region distal to the first end region and including a second outer surface portion.
  • the second outer surface portion has at least one of more adhesive strength, lower surface roughness, or more tack than the first outer surface portion. The second outer surface portion, then, is more likely to remain secured in the gluteal cleft than conventional fluid collection devices.
  • the fluid impermeable barrier also defines an opening extending longitudinally along the fluid impermeable barrier and configured to be positioned adjacent to a female urethra.
  • the fluid permeable body is positioned at least partially within the chamber to extend across at least a portion of the opening and configured to wick fluid away from the opening.
  • a fluid collection device includes a fluid impermeable barrier and a fluid permeable body.
  • the fluid impermeable barrier at least partially defines a chamber, an opening extending longitudinally along the fluid impermeable barrier and configured to be positioned adjacent to a female urethra, and an aperture extending therethrough.
  • At least a portion of the fluid impermeable barrier has a composition including oil and at least one of silicone and thermoplastic elastomer (TPE), the composition including about 60 oil parts per hundred rubber (phr) to about 200 oil phr based on 100 phr of styrene block co-polymer.
  • TPE thermoplastic elastomer
  • incorporación of the oil and at least one of silicone or TPE into the fluid impermeable barrier results in a softer material having more tack that is more likely to remain secured within the gluteal cleft.
  • the fluid permeable body is positioned at least partially within the chamber to extend across at least a portion of the opening and configured to wick fluid away from the opening.
  • a method of forming a fluid impermeable barrier of a fluid collection device includes inserting a composition including at least one of silicone or TPE into a barrier mold.
  • the barrier mold includes a first mold portion having a first mold surface and a second portion having a second mold surface more polished than the first mold surface.
  • the method also includes molding the composition in the barrier mold to form a fluid impermeable barrier having an inner surface at least partially defining a chamber, a first end region having a first outer surface portion interfacing the first mold surface, a second end region distal to the first end region and having a second outer surface portion interfacing the second mold surface, and an opening extending longitudinally along the fluid impermeable barrier.
  • the opening is configured to be positioned adjacent to a female urethra. Because the second mold surface is more polished than the first mold surface, the second outer surface portion is also more highly polished than the first outer surface portion, and thus has at least one of more adhesive strength, lower surface roughness, or more tack than the first outer surface portion. The second outer surface portion, then, is more likely to remain secured in the gluteal cleft than conventional fluid collection devices.
  • a method of forming a fluid impermeable barrier of a fluid collection device includes inserting a composition into at least a portion of a barrier mold, the composition including at least one of silicone or TPE and about 60 oil phr to about 200 oil phr based on 100 phr of styrene block co-polymer.
  • the method also includes molding the composition in the barrier mold to form at least a portion of a fluid impermeable barrier defining a chamber and an opening extending therethrough, the opening configured to be positioned adjacent to a female urethra.
  • the method also includes removing the fluid impermeable barrier from the barrier mold.
  • the fluid collection devices disclosed herein are configured to collect fluids from an individual.
  • the fluids collected by the fluid collection devices may include urine.
  • the fluids collected by the fluid collection devices may also include at least one of vaginal discharge, penile discharge, reproductive fluids, blood, sweat, or other bodily fluids.
  • Fluid collection devices described herein may be used in fluid collection systems.
  • the fluid collection systems may include a fluid collection device, a fluid storage container, and a portable vacuum source.
  • Fluid e.g., urine or other bodily fluids
  • Fluid collected in the fluid collection device may be removed from the fluid collection device via a conduit which protrudes into an interior region of the fluid collection device.
  • a first open end of the conduit may extend into the fluid collection device to a reservoir therein.
  • the second open end of the conduit may extend into the fluid collection device or the portable vacuum source.
  • the suction force may be introduced into the interior region of the fluid collection device via the first open end of the conduit responsive to a suction (e.g., vacuum) force applied at the second end of the conduit.
  • a suction e.g., vacuum
  • Fluid collection devices described herein may be shaped and sized to be positioned adjacent to the opening of a female urethra or have a male urethra positioned therethrough (e.g., receive a penis therein).
  • the fluid collection device may include a fluid impermeable barrier at least partially defining a chamber (e.g., interior region of the fluid collection device) of the fluid collection device.
  • the fluid impermeable barrier also defines an opening extending therethrough from the external environment. The opening may be positioned adjacent to a female urethra or have a male urethra positioned therethrough.
  • the fluid collection device may include a fluid permeable body disposed within the fluid impermeable barrier.
  • the conduit may extend into the fluid collection device at a first end region, through one or more of the fluid impermeable barrier, fluid permeable body to a second end region of the fluid collection device. Exemplary fluid collection devices for use with the systems and methods herein are described in more detail below.
  • the portable vacuum source may be disposed in or on the fluid collection device.
  • the conduit may extend from the fluid collection device and attach to the portable vacuum source at a first point therein.
  • An additional conduit may attach to the portable vacuum source at a second point thereon and may extend out of the fluid collection device, and may attach to the fluid storage container.
  • a vacuum e.g., suction
  • Fluid such as urine, may be drained from the fluid collection device using the portable vacuum source.
  • FIG. 1A is an isometric view of a fluid collection device 100, according to an embodiment.
  • the fluid collection device 100 is an example of a female fluid collection device 100 that is configured to receive fluids from a female.
  • the fluid collection device 100 includes a fluid impermeable barrier 102 having a first end region 125 and a second end region 127.
  • the fluid impermeable barrier 102 at least partially defines a chamber 104 (e.g., interior region, shown in FIG. 1C) and includes an inward border or edge 129 defining an opening 106.
  • the fluid impermeable barrier 102 is substantially cylindrical in shape between the first end region 125 and the second end region 127.
  • the fluid impermeable barrier 102 may include other shapes, such as one or more of substantially planar surfaces, triangular, or other suitable shapes.
  • the opening 106 is formed in and extends longitudinally through the fluid impermeable barrier 102, thereby enabling fluids to enter the chamber 104 from outside of the fluid collection device 100.
  • the opening 106 may be configured to be positioned adjacent to a female urethra.
  • the fluid collection device 100 may be positioned proximate to the opening of the female urethra and urine may enter the interior region of the fluid collection device 100 via the opening 106.
  • the fluid collection device 100 is configured to receive the fluids into the chamber 104 via the opening 106.
  • the opening 106 may exhibit an elongated shape that is configured to extend from a first location below the urethral opening (e.g., at or near the anus or the vaginal opening) to a second location above the urethral opening (e.g., at or near the clitoris or the pubic hair).
  • the opening 106 may exhibit an elongated shape since the space between the legs of a female is relatively small when the legs of the female are closed, thereby only permitting the flow of the fluids along a path that corresponds to the elongated shape of the opening 106.
  • the opening 106 may extend longitudinally along the fluid impermeable barrier.
  • the opening 106 in the fluid impermeable barrier 102 may exhibit a width that is measured transverse to the longitudinal direction and may be at least about 10% of the circumference of the fluid collection device 100, such as about 25% to about 50%, about 40% to about 60%, about 50% to about 75%, about 65% to about 85%, or about 75% to about 100% of the circumference of the fluid collection device 100.
  • the opening 106 may exhibit a width that is greater than 50% of the circumference of the fluid collection device 100 since the vacuum (e.g., suction) through the conduit 108 pulls the fluid into the conduit 108.
  • the opening 106 may be vertically oriented (e.g., having a major axis parallel to the longitudinal axis of the device 100).
  • the opening 106 may be horizontally oriented (e.g., having a major axis perpendicular to the longitudinal axis of the device 100).
  • the inward border or edge 129 of the fluid impermeable barrier 102 defines the opening 106.
  • the edge 129 may include two opposing arced portions, the arced portions following the outer circumference or periphery of the substantially cylindrical fluid impermeable barrier 102.
  • the fluid impermeable barrier 102 may be configured to be attached to the individual, such as adhesively attached (e.g., with a hydrogel adhesive) to the individual.
  • a suitable adhesive is a hydrogel layer, such as those disclosed in U.S. Patent Application Publication No. 2017/0189225, the disclosure of which is incorporated herein by reference in its entirety.
  • the fluid impermeable barrier 102 may also temporarily store the fluids in the chamber 104.
  • the fluid impermeable barrier 102 may be formed of any suitable fluid impermeable materials, such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, a polycarbonate, etc.), polyurethane films, TPE, oil, rubber, thermoplastic polyurethane, another suitable material, or combinations thereof.
  • a fluid impermeable polymer e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, a polycarbonate, etc.
  • polyurethane films e.g., polyurethane films
  • TPE polyethylene
  • oil e.g., polyethylene terephthalate
  • thermoplastic polyurethane e.g., polyurethane films
  • the fluid impermeable barrier 102 substantially prevents the fluids from exiting the portions of the chamber 104 that are spaced from the opening
  • the fluid impermeable barrier 102 is flexible, allowing the fluid collection device 100 to bend or curve when positioned against the body of a wearer.
  • One or more TPEs may be combined with at least one of silicone and oil.
  • the fluid impermeable barrier 102 may include a composition having at least silicone and oil therein.
  • a fluid impermeable barrier 102 having oil in the amounts described below provide a fluid impermeable barrier 102 having a softer outer surface 107 that has more adhesive strength or tack than fluid impermeable barriers of conventional fluid collection devices.
  • a work of adhesion of the fluid impermeable barrier 102 may vary according to different embodiments.
  • the work of adhesion of the fluid impermeable barrier 102 may be about 200 gram seconds (gs) to about 3500 gs, about 200 gs to about 1850 gs, about 1850 gs to about 3500 gs, about 200 gs to about 1025 gs, about 1025 gs to about 1850 gs, about 1850 gs to about 2675 gs, about 2675 gs to about 3500 gs, about 200 gs to about 800 gs, about 600 gs to about 1200 gs, about 1000 gs to about 1600 gs, about 1400 gs to about 2000 gs, about 1800 gs to about 2400 gs, about 2200 gs to about 2800 gs, about 2600 gs to about 3200 gs, about 3000 gs to about 3600 gs, at
  • a tack of the fluid impermeable barrier 102 also may vary according to different embodiments.
  • the tack force of the fluid impermeable barrier 102 may be about 50 grams (g) to about 500 g, about 50 g to about 275 g, about 275 g to about 500 g, about 50 g to about 100 g, about 100 g to about 150 g, about 150 g to about 200 g, about 200 g to about 250 g, about 250 g to about 300 g, about 300 g to about 350 g, about 350 g to about 400 g, about 400 g to about 450 g, about 450 g to about 500 g, at least about 50 g, at least about 100 g, at least about 150 g, at least about 200 g, at least about 250 g, at least about 300 g, at least about 350 g, at least about 400 g, at least about 450 g, less than about 100 g, less than about 150 g, less than about 200
  • the type of oil in the fluid impermeable barrier 102 may vary according to different embodiments.
  • the fluid impermeable barrier 102 may include mineral oil.
  • the amount of oil in the fluid impermeable barrier 102 may vary according to different embodiments.
  • the fluid impermeable barrier 102 may include a composition having varying oil phr based on 100 phr of styrene block co-polymer, such as about 60 oil phr to about 200 oil phr, about 50 oil phr to about 100 oil phr, about 100 oil phr to about 150 oil phr, about 150 oil phr to about 200 oil phr, about 60 oil phr to about 80 oil phr, about 80 oil phr to about 100 oil phr, about 100 oil phr to about 120 oil phr, about 120 oil phr to about 140 oil phr, about 140 oil phr to about 160 oil phr, about 160 oil phr to about 180 oil phr, about 180 oil phr to about 200 oil phr, about 60 oil phr to about 70 oil phr, about 70 oil phr to about 80 oil phr,
  • the fluid impermeable barrier 102 may be air permeable.
  • the fluid impermeable barrier 102 may be formed of a hydrophobic material that defines a plurality of pores.
  • one or more portions of at least the outer surface of the fluid impermeable barrier 102 may be formed from a soft and/or smooth material, thereby reducing chaffing.
  • the fluid impermeable barrier 102 may include markings thereon, such as one or more markings to aid a user in aligning the device 100 on the wearer.
  • a line on the fluid impermeable barrier 102 may allow a healthcare professional to align the opening 106 over the urethra of the wearer.
  • the markings may include one or more of alignment guide or an orientation indicator, such as a stripe or hashes. Such markings may be positioned to align the device 100 to one or more anatomical features such as a pubic bone, etc.
  • the fluid collection device 100 may include a fluid permeable body 120 or layer disposed in the chamber 104.
  • the fluid permeable body 120 may cover or extend across at least a portion (e.g., all) of the opening 106.
  • the fluid permeable body 120 may be configured to wick any fluid away from the opening 106, thereby preventing the fluid from escaping the chamber 104.
  • the fluid permeable body 120 also may wick the fluid generally towards an interior of the chamber 104, as discussed in more detail below.
  • a portion of the fluid permeable body 120 may define a portion of an outer surface of the fluid collection device 100.
  • the portion of the fluid permeable body 120 defining the portion of the outer surface of the fluid collection device 100 may be the portion of the fluid permeable body 120 exposed by the opening 106 defined by the fluid impermeable barrier 102 that contacts the user.
  • the portion of the fluid permeable device defining the portion of the outer surface of the fluid collection device 100 may be free from coverage by gauze or other wicking material at the opening.
  • the fluid permeable body 120 may include any material that may wick the fluid.
  • the permeable properties referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as“permeable” and/or “wicking.” Such“wicking” may exclude absorption into the wicking material.
  • the fluid permeable body 120 may include a one-way fluid movement fabric. As such, the fluid permeable body 120 may remove fluid from the area around the female urethra, thereby leaving the urethra dry. The fluid permeable body 120 may enable the fluid to flow generally towards a reservoir 122 (shown in FIGS. 2A and 2B) of void space formed within the chamber 104.
  • the fluid permeable body 120 may include a porous or fibrous material, such as hydrophilic polyolefin.
  • the fluid permeable body 120 consists of or consists essentially of a porous or fibrous material, such as hydrophilic polyolefin.
  • polyolefin examples include, but are not limited to, polyethylene, polypropylene, polyisobutylene, ethylene propylene rubber, ethylene propylene diene monomer, or combinations thereof.
  • the porous or fibrous material may be extruded into a substantially cylindrically shape to fit within the chamber 104 of the fluid impermeable barrier 102.
  • the fluid permeable body 120 may include varying densities or dimensions.
  • the fluid permeable body 120 may be manufactured according to various manufacturing methods, such as molding, extrusion, or sintering. [0040] In some embodiments, the fluid permeable body 120 includes a singular and porous body.
  • the fluid permeable body 120 extends from the conduit 108 to interface the fluid impermeable barrier 102 and the opening 106.
  • a majority of the outer surface 109 (shown in FIG. 1C) of the fluid permeable body 120 interfaces with an inner surface 103 (shown in FIG. 1C) of the fluid impermeable barrier 106.
  • a singular fluid permeable body 120 may be advantageous to conventional systems, which typically require an air-laid nonwoven pad covered by a ribbed fabric compression bandage, because a singular fluid permeable body 120 reduced the number of components in the fluid collection device 100, reduces the assembly time of the fluid collection device 100, requires shelf-life data for only a single component, and provides a latex-free single component.
  • the singular porous material of the fluid permeable body 120 extends continuously between the opening 106 and the reservoir 122 to wick any fluid from the opening 106 directly to the reservoir 122.
  • the fluid collection device 100 in some embodiments, is free from a seal or cushioning ring on the inward edge 129 defining the opening 106.
  • the fluid permeable body 120 includes an outer surface 109 and a single layer or type of material between the opening 106 and the conduit 108 positioned within the fluid permeable body 120.
  • the fluid permeable body 120 may include two or more layers of fluid permeable materials and include no (or an absence of) more than two layers of material between the opening 106 and the conduit 108 positioned within the fluid permeable body 120.
  • the fluid collection device 100 may include a fluid permeable membrane covering or wrapping around at least a portion of a fluid permeable support, with both the fluid permeable membrane and the fluid permeable support being disposed in the chamber 104.
  • the fluid permeable membrane may cover or extend across at least a portion (e.g., all) of the opening 106.
  • the fluid permeable membrane may be configured to wick any fluid away from the opening 106, thereby preventing the fluid from escaping the chamber 104.
  • the permeable properties referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as“permeable” and/or“wicking.”
  • at least one of the fluid permeable membrane or the fluid permeable support include nylon configured to wick fluid away from the opening 106.
  • the material of the fluid permeable membrane and the fluid permeable support also may include natural fibers.
  • the material may have a coating to prevent or limit absorption of fluid into the material, such as a water repellent coating.
  • Such“wicking” may not include absorption into the wicking material. Put another way, substantially no absorption of fluid into the material may take place after the material is exposed to the fluid and removed from the fluid for a time.
  • the term“substantially no absorption” may allow for nominal amounts of absorption of fluid into the wicking material (e.g. , absorbency), such as less than about 10 wt% of the dry weight of the wicking material, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the wicking material.
  • the fluid permeable membrane may also wick the fluid generally towards an interior of the chamber 104, as discussed in more detail below.
  • the fluid permeable membrane may include any material that may wick the fluid.
  • the fluid permeable membrane may include fabric, such as a gauze (e.g. , a silk, linen, polymer based materials such as polyester, or cotton gauze), another soft fabric (e.g., jersey knit fabric or the like), or another smooth fabric (e.g. , rayon, satin, or the like). Forming the fluid permeable membrane from gauze, soft fabric, and/or smooth fabric may reduce chaffing caused by the fluid collection device 100.
  • the fluid permeable body 120 includes a fluid permeable support including a porous nylon structure (e.g., spun nylon fibers) and a fluid permeable membrane including gauze about or over the porous nylon structure.
  • a fluid permeable support including a porous nylon structure (e.g., spun nylon fibers) and a fluid permeable membrane including gauze about or over the porous nylon structure.
  • FIG. IB is a front view of a fluid collection device 100 in use on a female user 150.
  • the fluid permeable body 120 of the fluid collection device is positioned adjacent to a urethra of the user 150.
  • the fluid permeable body 120 is disposed within a chamber 104 (shown in FIGS. 2A and 2B) of the fluid impermeable barrier 102 of the fluid collection device 100 and is exposed to the urethra of the user 150 through the opening 106 in the fluid collection device 100.
  • the fluid collection device 100 may be secured to the user with any of a number of securing devices. Fluids received in the chamber 104 of the fluid collection device 100 from the urethra may be removed through the conduit 108.
  • FIG. 1 is a front view of a fluid collection device 100 in use on a female user 150.
  • the fluid collection device 100 also includes conduit 108 that is at least partially disposed in the chamber 104.
  • the conduit 108 e.g., a tube
  • the conduit 108 includes an inlet 110 at a second end region 127 of the fluid impermeable barrier 102 and an outlet 112 at a first end region 125 of the fluid impermeable barrier 102 positioned downstream from the inlet 110.
  • the conduit 108 provides fluid communication between an interior region of the chamber 104 and a fluid storage container (not shown) or a portable vacuum source (not shown).
  • the conduit 108 may directly or indirectly fluidly couple the interior region of the chamber 104 and/or the reservoir 122 with the fluid storage container or the portable vacuum source.
  • the fluid permeable body 120 defines a bore 202 extending through the fluid permeable body 120 from a first body end 121 of the fluid permeable body 120 to a second body end 123 of the fluid permeable body 120 distal to the first body end 120.
  • the bore 202 extends only partially into the fluid permeable body from the first body end 121 of the fluid permeable body 120.
  • the conduit 108 is at least partially disposed in the chamber 104 and interfaces at least a portion of the bore 202 of the fluid permeable body 120.
  • the conduit 108 may extend into the fluid impermeable barrier 102 from the first end region 125 (e.g., proximate to the outlet 112) and may extend through the bore 202 to the second end region 127 (e.g., opposite the first end region 125) to a point proximate to the reservoir 122 such that the inlet 110 is in fluid communication with the reservoir 122.
  • the inlet 110 is positioned in the reservoir 122.
  • the inlet 110 may be positioned flush with or behind an end of the fluid permeable body 120 that partially defines the reservoir 122.
  • the fluid collected in the fluid collection device 100 may be removed from the interior region of the chamber 104 via the conduit 108.
  • the conduit 108 may include a flexible material such as plastic tubing (e.g., medical tubing).
  • plastic tubing may include a TPE, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc., tubing.
  • the conduit 108 may include silicone or latex.
  • the fluid impermeable barrier 102 may store fluids in the reservoir 122 therein.
  • the reservoir 122 is an unoccupied portion of the chamber 104 and is void of other material.
  • the reservoir 122 is defined at least partially by the fluid permeable body 120 and the fluid impermeable barrier 102.
  • the reservoir 122 may be located at the portion of the chamber 104 that is closest to the inlet 110 (e.g. , the second end region). Accordingly, in the embodiment in FIG.2A, the reservoir 122 is defined by the second body end 123 of the fluid permeable body 120 and the second end region 127 of the fluid impermeable barrier 122.
  • the reservoir 122 may be located at the portion of the chamber 104 that is closest to the inlet 110 (e.g., the second end region).
  • the reservoir 122 also may be located at different locations in the chamber 104.
  • the reservoir 122 may be located at the end of the chamber 104 that is closest to the outlet 112.
  • the conduit 108 may extend through the first region 125 of the fluid impermeable barrier 102 to the reservoir 122 without extending through the fluid permeable body 120. Accordingly, in these and other embodiments, the fluid permeable body 120 may be free from the bore.
  • the fluid collection device 100 may include multiple reservoirs, such as a first reservoir that is located at the portion of the chamber of the chamber 104 that is closest to the inlet 110 (e.g., second end region) and a second reservoir that is located at the portion of the of the chamber 104 that is closest to the outlet 112 (e.g., first end region).
  • the fluid permeable body 120 is spaced from at least a portion of the conduit 108 and the reservoir 122 may be the space between the fluid permeable body 120 and the conduit 108.
  • the fluid impermeable barrier 102 and the fluid permeable body 120 may be configured to have the conduit 108 at least partially disposed in the chamber 104.
  • the fluid permeable body 120 may be configured to form a space that accommodates the conduit 108, such as the bore 202.
  • the fluid impermeable barrier 102 may define an aperture 124 sized to receive the conduit 108 (e.g., at least one tube).
  • the at least one conduit 108 may be disposed in the chamber 104 via the aperture 124.
  • the apertures 124 may be configured to form an at least substantially fluid tight seal against the conduit 108 or the at least one tube thereby substantially preventing the fluids from escaping the chamber 104.
  • the conduit 108 may extend through the fluid permeable body 120 and at least partially into the reservoir 122, as shown in FIG. 2A. In some embodiments, the conduit 108 may extend through the fluid permeable body 120 and terminate at or before the second body end 123 of the fluid permeable body 120 such that the conduit 108 does not extend into the reservoir 122 (or the reservoir 122 is absent of the conduit 108). For example, as shown in FIG. 2B, an end of the conduit 108 may be generally flush or coplanar with the second body end 123 of the fluid permeable body 120. In other embodiments, the end of the conduit 108 may be recessed from the second body end 123 of the fluid permeable body 120. The end of the conduit 108 also may be selectively moveable between partially extending into the reservoir 122 (shown in FIG. 2A) and recessed from or flush with the second body end 123 of the fluid permeable body (shown in FIG. 2B).
  • the conduit 108 is configured to provide fluid communication with and at least partially extend between one or more of a fluid storage containers (not shown) and a portable vacuum source (not shown).
  • the conduit 108 may be configured to be fluidly coupled to and at least partially extend between one or more of the fluid storage containers and the portable vacuum source.
  • the conduit 108 is configured to be directly connected to the portable vacuum source (not shown).
  • the conduit 108 may extend from the fluid impermeable barrier 102 by at least one foot, at least two feet, at least three feet, or at least six feet.
  • the conduit 108 is configured to be indirectly connected to at least one of the fluid storage container (not shown) or the portable vacuum source (not shown).
  • the conduit may be frosted or opaque (e.g., black) to obscure visibility of the fluids therein.
  • the conduit is secured to a wearer’s skin with a catheter securement device, such as a STATLOCK® catheter securement device available from C. R. Bard, Inc., including but not limited to those disclosed in U.S. Patent Nos. 6,117,163; 6,123,398; and 8,211,063, the disclosures of which are all incorporated herein by reference in their entirety.
  • the inlet 110 and the outlet 112 are configured to provide fluid communication (e.g., directly or indirectly) between the portable vacuum source (not shown) and the chamber 104 (e.g., the reservoir 122).
  • the inlet 110 and the outlet 112 of the conduit 108 may be configured to directly or indirectly fluidly couple the portable vacuum source to the reservoir 122.
  • the inlet 110 and/or the outlet 112 may form a male connector.
  • the inlet 110 and/or the outlet 112 may form a female connector.
  • the inlet 110 and/or the outlet 112 may include ribs that are configured to facilitate secure couplings.
  • the inlet 110 and/or the outlet 112 may form a tapered shape.
  • the inlet 110 and/or the outlet 112 may include a rigid or flexible material.
  • Locating the inlet 110 at or near a gravimetrically low point of the chamber 104 enables the conduit to receive more of the fluids than if inlet 110 was located elsewhere and reduce the likelihood of pooling (e.g., pooling of the fluids may cause microbe growth and foul odors).
  • the fluids in the fluid permeable body 120 may flow in any direction due to capillary forces.
  • the fluids may exhibit a preference to flow in the direction of gravity, especially when at least a portion of the fluid permeable body 120 is saturated with the fluids.
  • the portable vacuum source applies a vacuum/suction in the conduit 108
  • the fluid(s) in the chamber 104 e.g., such as in the reservoir 122 positioned at the first end region 125, the second end region 127, or other intermediary positions within the chamber 104
  • the fluid(s) in the chamber 104 may be drawn into the inlet 110 and out of the fluid collection device 100 via the conduit 108.
  • the conduit 108 is configured to be at least insertable into the chamber 104.
  • the conduit 108 may include one or more markers 131 (shown in FIG. 1) on an exterior thereof that are configured to facilitate insertion of the conduit 108 into the chamber 104.
  • the conduit 108 may include one or more markings thereon that are configured to prevent over or under insertion of the conduit 108, such as when the conduit 108 defines an inlet 110 that is configured to be disposed in or adjacent to the reservoir 122.
  • the conduit 108 may include one or more markings thereon that are configured to facilitate correct rotation of the conduit 108 relative to the chamber 104.
  • the one or more markings may include a line, a dot, a sticker, or any other suitable marking.
  • the conduit 108 may extend into the fluid impermeable barrier 102 from the first end region (e.g., proximate to the outlet 112) and may extend to the second end region (e.g., opposite the first end region) to a point proximate to the reservoir 122 such that the inlet 110 is in fluid communication with the reservoir 122.
  • the conduit 108 may enter the second end region and the inlet 110 may be disposed in the second end region (e.g., in the reservoir 122). The fluid collected in the fluid collection device 100 may be removed from the interior region of the chamber 104 via the conduit 108.
  • the conduit 108 may include a flexible material such as plastic tubing (e.g., medical tubing) as disclosed herein.
  • the conduit 108 may include one or more portions that are resilient, such as to by having one or more of a diameter or wall thickness that allows the conduit to be flexible.
  • one or more components of the fluid collection device 100 may include an antimicrobial material, such as an antibacterial material where the fluid collection device may contact the wearer or the bodily fluid of the wearer.
  • the antimicrobial material may include an antimicrobial coating, such as a nitrofurazone or silver coating.
  • the antimicrobial material may inhibit microbial growth, such as microbial growth due to pooling or stagnation of the fluids.
  • one or more components of the fluid collection device 100 e.g., impermeable barrier 102, conduit 108, etc.
  • the conduits 108 may include or be operably coupled to a flow meter (not shown) to measure the flow of fluids therein, one or more securement devices (e.g., a StatLock securement device, not shown) or fittings to secure the conduit 108 to one or more components of the systems or devices disclosed herein (e.g., portable vacuum source or fluid storage container), or one or more valves to control the flow of fluids in the systems and devices herein.
  • a flow meter not shown
  • securement devices e.g., a StatLock securement device, not shown
  • fittings to secure the conduit 108 to one or more components of the systems or devices disclosed herein (e.g., portable vacuum source or fluid storage container), or one or more valves to control the flow of fluids in the systems and devices herein.
  • At least one of portion of the conduit 108 of the fluid collection devices or systems herein may be formed of an at least partially opaque material which may obscure the fluids that are present therein.
  • a first section of the conduit 108 disclosed herein may be formed of an opaque material or translucent material while a second section of the conduit 108 may be formed of a transparent material or translucent material.
  • the first section may include transparent or translucent material. Unlike the opaque or nearly opaque material, the translucent material allows a user of the devices and systems herein to visually identify fluids or issues that are inhibiting the flow of fluids within the conduit 108.
  • the system of fluid collection device may include moisture sensors (not shown) disposed inside of the chamber of the fluid collection device.
  • the moisture sensor may be operably coupled to a controller or directly to the portable vacuum source, and may provide electrical signals indicating that moisture is or is not detected in one or more portions of the chamber.
  • the moisture sensor(s) may provide an indication that moisture is present, and responsive thereto, the controller or portable vacuum device may direct the initiation of suction to the chamber to remove the fluid therefrom.
  • Suitable moisture sensors may include capacitance sensors, volumetric sensors, potential sensors, resistance sensors, frequency domain reflectometry sensors, time domain reflectometry sensors, or any other suitable moisture sensor.
  • the moisture sensors may detect moisture in the chamber and may provide a signal to the controller or portable vacuum source to activate the portable suction device.
  • the fluid collection device 300 may include any of the features described in relation to the fluid collection device 100.
  • the fluid collection device 300 includes a fluid impermeable barrier 302 having a first end region 325 extending from a first end 306 of the fluid impermeable barrier 302 and a second end region 327 extending from a second end 311 of the fluid impermeable barrier 302 towards the first end region 325.
  • the first end region 325 includes a first outer surface portion 305 and the aperture 124, and the second end region includes a second outer surface portion 310.
  • the fluid impermeable barrier 302 also may include a longitudinal length L extending from the first end 306 to the second end 311.
  • the first outer surface portion 305 may extend a first length Li along the longitudinal length L
  • the second outer surface portion 310 may extend a second length L2 along the longitudinal length L.
  • the second length L2 may vary according to different embodiments.
  • the second length L2 may be at least about one-tenth the longitudinal length L, at least about one-fifth the longitudinal length L, at least about one-fourth the longitudinal length L, at least about one- third the longitudinal length L, at least about one -half the longitudinal length L, about one- tenth to about one-half the longitudinal length L, about one-fifth to about one-half the longitudinal length L, about one-fourth to about one-half the longitudinal length L, about one-third to about one -half the longitudinal length L, about one-tenth the longitudinal length L, about one-fifth the longitudinal length L, about one-fourth the longitudinal length L, about one-third the longitudinal length L, about one-half the longitudinal length L, less than about one-tenth the longitudinal length L, less than about one-fifth the longitudinal length L, less than about one-fourth the longitudinal length L, less than about one-third the longitudinal length L, or less than about one-half the longitudinal length L.
  • the longitudinal length L of the fluid impermeable barrier 302 may vary according different embodiments.
  • the fluid impermeable barrier 302 may include a longer longitudinal length than conventional fluid collection devices. A longer longitudinal length is advantageous to shorter, conventional fluid collection devices because a longer fluid impermeable barrier 302 allows for easier placement and use of the fluid collection device 300 on obese or larger patients.
  • the fluid impermeable barrier 102 also may include any of the longitudinal lengths and lateral widths described in relation to the fluid impermeable barrier 302.
  • the longitudinal length L of the fluid impermeable barrier 302 may be about
  • the fluid impermeable barrier 302 also may include a diameter or lateral width L w .
  • the lateral width L w of the fluid impermeable barrier may be about 0.5 inch (about 1.3 cm) to about 2.0 inches (about 5.1 cm), about 0.5 inch to about 1.5 inches (about 3.8 cm), about 0.5 inch to about 1.25 inches (about 3.18 cm), about 0.5 inches to about 1.0 inch (about 2.5 cm), about 0.5 inch to about 0.75 inch (about 1.9 cm), about 0.75 inch to about 2.0 inches, about 0.75 inch to about 1.5 inches, about 0.75 inch to about 1.25 inches, about 0.75 inches to about 1.0 inch, about 1.0 inch to about 2.0 inches, about 1.0 inch to about 1.0 inch to about 1.0 inch, about 1.0 inch to about 2.0 inches, about 1.0 inch to about
  • the first outer surface portion 305 of the first end region 325 has different properties than the second outer surface portion 310 of the second end region 327.
  • the second outer surface portions 310 may include a base securement area configured to improve securement of the fluid collection device 300 to a user.
  • the second outer surface portion 327 may have a lower surface roughness, more tack, and/or more adhesive strength than the first outer surface portion.
  • the transition between the first outer surface portion 305 of the first end region 325 and the second outer surface portion 310 of the second end region 327 is sharp or abrupt.
  • the transition between the first outer surface portion 305 of the first end region 325 and the second outer surface portion 310 of the second end region 327 is gradual and the properties of the outer surface of the fluid impermeable barrier 302 between the first outer surface portion 305 and the second out surface portion 310 may gradually transition or change.
  • the first end region 325 and the second end region 327 may include different compositions from one another, thereby resulting in the first outer surface portion 305 having different properties than the second outer surface portion 310.
  • a composition of the second end region 327 may include more oil than a composition of the first end region 325, thereby resulting in the second outer surface portion 310 being more soft and/or having more adhesive strength or tack than first outer surface portion 305.
  • the compositions of both the first end region 325 and the second end region 327 also may include other components as described above in relation to the fluid impermeable barrier 102.
  • the amount of oil in the second end region 327 may vary according to different embodiments.
  • second end region 327 may include a composition having varying oil phr based on 100 phr of styrene block co-polymer, such as about 60 oil phr to about 200 oil phr, about 50 oil phr to about 100 oil phr, about 100 oil phr to about 150 oil phr, about 150 oil phr to about 200 oil phr, about 60 oil phr to about 80 oil phr, about 80 oil phr to about 100 oil phr, about 100 oil phr to about 120 oil phr, about 120 oil phr to about 140 oil phr, about 140 oil phr to about 160 oil phr, about 160 oil phr to about 180 oil phr, about 180 oil phr to about 200 oil phr, about 60 oil phr to about 70 oil phr, about 70 oil phr to about 80 oil phr, about 80 oil
  • the composition of the first end region 325 may have a lower oil content than the second end region 327.
  • the first end region 325 may include a composition having no oil or having varying oil phr based on 100 phr of styrene block co-polymer, such as about 0 oil phr to about 150 oil phr, about 1 oil phr to about 50 oil phr, about 50 oil phr to about 100 oil phr, about 100 oil phr to about 150 oil phr, about 1 oil phr to about 20 oil phr, about 20 oil phr to about 40 oil phr, about 40 oil phr to about 60 oil phr, about 60 oil phr to about 80 oil phr, about 80 oil phr to about 100 oil phr, about 100 oil phr to about 120 oil phr, about 120 oil
  • the second end region 327 may be more highly polished than the first end region 325, thereby resulting in the first outer surface portion 305 having different properties than the second outer surface portion 310.
  • the second end region 327 may have lower surface roughness than the first end region 325 due at least in part to formation of the fluid impermeable barrier 302 in a mold having different surface finishes.
  • the fluid impermeable barrier 302 may be molded in a barrier mold having a first mold portion that interfaces that first outer surface portion 305 and a second mold portion that interfaces the second outer surface portion 310, the second mold portion being more polished or having a smoother surface finish than the first mold portion.
  • the resulting second outer surface portion 310 has more adhesive strength, lower surface roughness, and/or greater tack than the first outer surface portion 305.
  • the second mold portion may include a surface having a Society of the Plastics Industry (SPI) rating of Al, A2, A3, Bl, B2, or B3.
  • SPI Society of the Plastics Industry
  • the corresponding second outer surface portion 310 also may include a SPI rating approximately equal to the surface of the second mold portion, thus resulting in the second outer surface portion 310 having an SPI rating of about Al, A2, A3, Bl, B2, or B3.
  • the first mold portion may include a surface having a SPI rating of Cl, C2, C3, Dl, D2, or D3.
  • the corresponding first outer surface portion 305 also may include a SPI rating approximately equal to the surface of the first mold portion, thus resulting in the first outer surface portion 305 having a SPI rating of Cl, C2, C3, Dl, D2, or D3.
  • the second end region 327 may include an adhesive on the second outer surface portion 310, thereby resulting in the first outer surface portion 305 having different properties than the second outer surface portion 310.
  • the adhesive may be applied to the second outer surface portion 310 after the fluid impermeable barrier 302 is formed, and may include any adhesive suitable for use with skin, such as a hydrogel adhesive.
  • the resulting second outer surface portion 310 has more adhesive strength and/or greater tack than the first outer surface portion 305.
  • FIG. 4 is a flow diagram of a method 400 of forming a fluid impermeable barrier of a fluid collection device.
  • the method 400 may optionally include an act 405 of mixing oil with at least one of silicone or TPE to form a composition.
  • the method also includes an act 410 of inserting the composition into a barrier mold.
  • the method also includes an act 415 of molding the composition in the barrier mold to form a fluid impermeable barrier.
  • the method also includes an act 420 of removing the fluid impermeable barrier from the barrier mold
  • the method 400 includes the act 405 of mixing oil with at least one of silicone or TPE to form a composition, the composition having varying oil phr based on 100 phr of styrene block co-polymer, such as about 60 oil phr to about 200 oil phr, about 50 oil phr to about 100 oil phr, about 100 oil phr to about 150 oil phr, about 150 oil phr to about 200 oil phr, about 60 oil phr to about 80 oil phr, about 80 oil phr to about 100 oil phr, about 100 oil phr to about 120 oil phr, about 120 oil phr to about 140 oil phr, about 140 oil phr to about 160 oil phr, about 160 oil phr to about 180 oil phr, about 180 oil phr to about 200 oil phr, about 60 oil phr to about 70
  • the act 405 of mixing oil with at least one of silicone or TPE to form a composition includes mixing one or more constituents to form a first composition and mixing oil with at least one of silicone or TPE to form a second composition having a higher oil content than the first composition.
  • Mixing one or more constituents to form the first composition may include mixing oil with at least one of silicone or TPE to form the first composition, with the first composition having a lower oil content than the second composition.
  • Mixing at least one of silicone or TPE with oil to form the first composition may include mixing oil with at least one of silicone or TPE to form the first composition having varying oil phr based on 100 phr of styrene block co polymer, such as about 0 oil phr to about 150 oil phr, about 1 oil phr to about 50 oil phr, about 50 oil phr to about 100 oil phr, about 100 oil phr to about 150 oil phr, about 1 oil phr to about 20 oil phr, about 20 oil phr to about 40 oil phr, about 40 oil phr to about 60 oil phr, about 60 oil phr to about 80 oil phr, about 80 oil phr to about 100 oil phr, about 100 oil phr to about 120 oil phr, about 120 oil phr to about 140 oil phr, about 140 oil phr to about 160 oil
  • Mixing oil with at least one of silicone or TPE to form the second composition may include mixing oil with at least one of silicone or TPE to form the second composition having varying oil phr based on 100 phr of styrene block co-polymer, such as about 60 oil phr to about 200 oil phr, about 50 oil phr to about 100 oil phr, about 100 oil phr to about 150 oil phr, about 150 oil phr to about 200 oil phr, about 60 oil phr to about 80 oil phr, about 80 oil phr to about 100 oil phr, about 100 oil phr to about 120 oil phr, about 120 oil phr to about 140 oil phr, about 140 oil phr to about 160 oil phr, about 160 oil phr to about 180 oil phr, about 180 oil phr to about 200 oil phr, about 60 oil phr to
  • a composition including oil and at least one of silicone or TPE may be provided having been previously mixed together. Accordingly, the method 400 may sometimes not include mixing oil with at least one of silicone or TPE.
  • the composition including oil and at least one of silicone or TPE may include, for example, a stock material including oil and at least one of silicone or TPE.
  • the act 410 of inserting the composition into the barrier mold may include inserting the composition including at least one of silicone or TPE into the barrier mold.
  • the barrier mold to which the composition including at least one of silicone or TPE is inserted may include a first mold portion having a first mold surface and a second portion having a second mold surface more polished and/or having a lower surface roughness than the first mold surface.
  • the second mold surface may have an SPI rating of Al, A2, A3, Bl, B2, or B3
  • the first mold surface may have an SPI rating of Cl, C2, C3, Dl, D2, or D3.
  • the method 400 also may include inserting the composition into an injection mold for injection molding of the fluid impermeable barrier. In some embodiments, inserting the method 400 also may include inserting the composition into a molding for liquid silicone or TPE rubber molding of the fluid impermeable barrier.
  • the act 410 of inserting the composition into the barrier mold also may include inserting the first composition into the first mold portion of the barrier mold and inserting the second composition into the second mold portion of the barrier mold.
  • the act 410 of inserting the composition into the barrier mold may include inserting the composition including oil and at least one of silicone or TPE into at least a portion of the of the barrier mold.
  • the act of inserting the composition including oil and at least one of silicone or TPE into at least a portion of the barrier mold also may include inserting an additional composition into an additional portion of the barrier mold.
  • the additional composition may include at least one of silicone or TPE and also have a lower oil content than the composition.
  • inserting the additional composition into the additional portion of the barrier mold includes inserting the additional composition into the additional portion of the barrier mold having a first mold surface, and inserting the composition into at least a portion of the barrier mold includes inserting the composition into the portion of the barrier mold having a second mold surface more polished than the first mold surface.
  • the act 415 of molding the composition in the barrier mold to form the fluid impermeable barrier may include one or more of heating and cooling the composition in the barrier mold to form the fluid impermeable barrier.
  • the act 415 of molding the composition in the barrier mold to form a fluid impermeable barrier may include molding the composition in the barrier mold to form at least a portion of a fluid impermeable barrier defining a chamber and an opening extending therethrough, with the opening configured to be positioned adjacent to a female urethra.
  • the act 415 of molding the composition in the barrier mold may include molding the composition in the barrier mold to form the fluid impermeable barrier having a first end region including the additional or first composition having a lower oil content, and a second end region distal to the first end region and including the second composition or the composition having a higher oil content.
  • the act 415 of molding the composition in the barrier mold to form a fluid impermeable barrier may include molding the composition in the barrier mold to form a fluid impermeable barrier having an inner surface at least partially defining a chamber, a first end region having a first outer surface portion interfacing the first mold surface, a second end region distal to the first end region and having a second outer surface portion interfacing the second mold surface, and an opening extending longitudinally along the fluid impermeable barrier.
  • the opening is configured to be positioned adjacent to a female urethra, and the second outer surface portion has more adhesive strength than the first outer surface portion.
  • the method 400 also may include applying an adhesive to the second outer surface portion of the fluid impermeable barrier after the fluid impermeable barrier has been molded.
  • the adhesive applied to the second outer surface portion may include any adhesive suitable for use with skin, such as a hydrogel adhesive.
  • a suitable adhesive is a hydrogel layer, such as those disclosed in U.S. Patent Application Publication No. 2017/0189225, the disclosure of which is incorporated herein by reference in its entirety.
  • the resulting second outer surface portion has more adhesive strength and/or greater tack than the first outer surface portion.
  • the acts 405, 410, 415, and 420 of the method 400 are for illustrative purposes.
  • the acts 405, 410, and 415 of the method 400 may be performed in different orders, split into multiple acts, modified, supplemented, or combined.
  • one or more of the acts 405, 410, and 415 of the method 400 may be omitted from the method 400.
  • Any of the acts 405, 410, and 415 may include forming any of the fluid impermeable barriers disclosed herein.
  • FIG. 5 is a flow diagram of a method 500 of assembling the fluid collection devices and/or fluid collection systems disclosed herein, according to an embodiment.
  • the method 500 may include an act 505, which recites providing a fluid impermeable barrier.
  • the fluid impermeable barrier at least partially defines a chamber and also an opening extending therethrough.
  • the opening is configured to be positioned adjacent to a female urethra or have a male urethra positioned therethrough.
  • the fluid permeable body may include a singular porous hydrophilic polyolefin material extruded, molded, or sintered to a substantially cylindrical shape
  • the method may include an act 510, which recites inserting a substantially cylindrical and fluid permeable body into the chamber of the fluid impermeable barrier.
  • act 510 recites inserting a substantially cylindrical and fluid permeable body into the chamber of the fluid impermeable barrier.
  • the fluid permeable body interfaces at least a portion of the fluid impermeable barrier and covers at least a portion of the opening.
  • the fluid permeable body includes a singular porous material that is substantially cylindrical in shape and configured to wick any fluid away from the opening.
  • the act 510 may include inserting the fluid permeable body into the chamber of the fluid impermeable barrier such that a reservoir is defined within the chamber by a second body end of the fluid permeable body distal to the first body end and a second end region of the fluid impermeable barrier distal to the aperture. In some embodiments, the act 510 may include inserting the substantially cylindrical and fluid permeable body into the chamber of the fluid impermeable barrier such that the fluid permeable body and the conduit fill substantially all of the chamber.
  • the method may include an act 515, which recites inserting an inlet of a conduit into the fluid impermeable body.
  • the conduit may be inserted into the fluid impermeable body through an aperture defined by the fluid impermeable barrier at a first end region of the fluid impermeable barrier.
  • the act 515 may include inserting the inlet of the conduit into the bore at the first body end, through the bore of the fluid permeable body, through the second body end of the fluid permeable body, and into the reservoir such that the conduit extends from the reservoir, through the fluid permeable body, through the aperture to outside the fluid impermeable barrier.
  • the method may include an act 520, which recites inserting the inlet of the conduit at least partially into a bore at a first body end of the fluid permeable body.
  • the bore extends at least partially through the fluid permeable body and is defined by the fluid permeable body.
  • the conduit interfaces at least a portion of the fluid permeable body.
  • the acts 505, 510, 515, and 520 of the method 500 are for illustrative purposes.
  • the acts 505, 510, 515, and 520 of the method 500 may be performed in different orders, split into multiple acts, modified, supplemented, or combined.
  • one or more of the acts 505, 510, 515, and 520 of the method 500 may be omitted from the method 500.
  • Any of the acts 505, 510, 515, and 520 may include using any of the fluid collection devices or systems disclosed herein.
  • FIG. 6 is a flow diagram of a method 600 for collecting fluids.
  • the method 600 includes an act 605 of positioning a fluid permeable body of a fluid collection device adjacent to a female urethra of a user.
  • the fluid permeable body is disposed within a chamber of a fluid impermeable barrier of the fluid collection device and exposed to the female urethra of the user through an opening in the fluid collection device defined by the fluid impermeable barrier.
  • the method 600 also includes an act 610 of securing the fluid collection device to the user.
  • the method 600 also includes an act 615 of receiving fluids from the female urethra into the chamber of the fluid collection device.
  • the method 600 an act of applying suction effective to suction the fluids from the chamber via a conduit disposed therein.
  • Acts 605, 610, and 615 of the method 600 are for illustrative purposes.
  • the acts 605, 610, and 615 of the method 600 may be performed in different orders, split into multiple acts, modified, supplemented, or combined.
  • one or more of the acts 605, 610, and 615 of the method 600 may be omitted from the method 600.
  • Any of the acts 605, 610, and 615 may include using any of the fluid collection devices or systems disclosed herein.
  • FIG. 7 is a block diagram of a system 10 for fluid collection, according to an embodiment.
  • the system 10 includes a fluid collection device 12, a fluid storage container 14, and a portable vacuum source 16.
  • the fluid collection device 12 may include any of the fluid collection devices described herein, such as the fluid collection device 100.
  • the fluid collection device 12, the fluid storage container 14, and the portable vacuum source 16 may be fluidly coupled to each other via one or more conduits 17.
  • the conduit 17 may include any of the conduits described herein, such as the conduit 108.
  • the fluid collection device 12 may be operably coupled to one or more of the fluid storage container 14 or the portable vacuum source via the conduit 17.
  • Fluid (e.g., urine or other bodily fluids) collected in the fluid collection device 12 may be removed from the fluid collection device 12 via the conduit 17, which protrudes into an interior region of the fluid collection device 12.
  • a first open end of the conduit 17 may extend into the fluid collection device 12 to a reservoir therein.
  • the second open end of the conduit 17 may extend into the fluid collection device 12 or the portable vacuum source 16.
  • the suction force may be introduced into the interior region of the fluid collection device 12 via the first open end of the conduit 17 responsive to a suction (e.g., vacuum) force applied at the second end of the conduit 17.
  • the suction force may be applied to the second open end of the conduit 17 by the portable vacuum source 16 either directly or indirectly.
  • the suction force may be applied indirectly via the fluid storage container 14.
  • the second open end of the conduit 17 may be disposed within the fluid storage container 14 and an additional conduit 17 may extend from the fluid storage container 14 to the portable vacuum source 16.
  • the portable vacuum source 16 may apply suction to the fluid collection device 12 via the fluid storage container 14.
  • the suction force may be applied directly via the fluid storage container 14.
  • the second open end of the conduit 17 may be disposed within the portable vacuum source 16.
  • An additional conduit 17 may extend from the portable vacuum source 16 to a point outside of the fluid collection device 12, such as to the fluid storage container 14.
  • the portable vacuum source 16 may be disposed between the fluid collection device 12 and the fluid storage container 14.
  • the fluid collection device 12 may be shaped and sized to be positioned adjacent to a female urethra.
  • the fluid collection member of the fluid collection device 12 may include a fluid impermeable barrier at least partially defining a chamber (e.g., interior region of the fluid collection device member) of the fluid collection device 12.
  • the fluid collection device 12 may include a softer, thinner fluid impermeable barrier than conventional fluid collection devices.
  • the fluid impermeable barrier also defines an opening extending therethrough from the external environment. The opening may be positioned on the fluid collection member to be aligned adjacent to a female urethra.
  • the fluid collection member of the fluid collection device 12 may include a fluid permeable body disposed within the fluid impermeable barrier.
  • the fluid permeably body may include a fluid permeable membrane and fluid permeable support disposed within the fluid permeable membrane.
  • the conduit 17 may extend into the fluid collection device 12 at a first end region, through one or more of the fluid impermeable barrier, fluid permeable membrane, or the fluid permeable support to a second end region of the fluid collection member of the fluid collection device 12.
  • Example fluid collection devices for use with the systems and methods herein are described in more detail below.
  • the fluid storage container 14 may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing bodily fluids such as urine.
  • the conduit 17 may extend from the fluid collection device 12 and attach to the fluid storage container 14 at a first point therein.
  • An additional conduit 17 may attach to the fluid storage container 14 at a second point thereon and may extend and attach to the portable vacuum source 16.
  • the fluid storage container 14 may include a container fluidly coupled to a first conduit section that is also fluidly coupled to the fluid collection member of the fluid collection device 12.
  • the container may be fluidly coupled to a second section of the conduit 17 that is also fluidly coupled to a portable vacuum source.
  • the portable vacuum source 16 may provide a vacuum/suction through the container to the fluid collection member to provide suction in the chamber of the fluid collection member. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection device 12 via the fluid storage container 14. As the fluid is drained from the chamber, the fluid may travel through the first section of conduit to the fluid storage container where it may be retained. Fluid, such as urine, may be drained from the fluid collection device 12 using the portable vacuum source 16.
  • a vacuum e.g., suction
  • the portable vacuum source 16 may be disposed in or on the fluid collection device 12.
  • the conduit 17 may extend from the fluid collection device and attach to the portable vacuum source 16 at a first point therein.
  • An additional conduit 17 may attach to the portable vacuum source 16 at a second point thereon and may extend out of the fluid collection device 12, and may attach to the fluid storage container 14. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection device 12 via the fluid storage container 14.
  • a vacuum e.g., suction
  • the portable vacuum source 16 may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum.
  • the portable vacuum source 16 may provide a vacuum or suction to remove fluid from the fluid collection member of the fluid collection device 12.
  • the portable vacuum source 16 may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even manual power (e.g., a hand operated vacuum pump).
  • the portable vacuum source 16 may be sized and shaped to fit outside of, on, or within the fluid collection device 12.
  • the portable vacuum source 16 may include one or more miniaturized pumps or one or more micro pumps.
  • the portable vacuum sources 16 disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the portable vacuum source 16.
  • the portable vacuum sources 16 disclosed herein may provide a portable means of providing a suction or vacuum that allows use of the devices and systems herein outside of hospital or care facility environments where vacuum lines are plumbed into patient rooms or large (e.g., larger or heavier than a patient can readily carry) vacuum sources are located.
  • a portable vacuum source may be small and light enough to be carried by a user (e.g., patient) or aid (e.g., nurse) during transportation of the user.
  • the term“about” or“substantially” refers to an allowable variance of the term modified by“about” or“substantially” by ⁇ 10% or ⁇ 5%. Further, the terms“less than,”“or less,”“greater than,”“more than,” or“or more” include, as an endpoint, the value that is modified by the terms“less than,”“or less,”“greater than,” “more than,” or“or more.”

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  • Life Sciences & Earth Sciences (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Mechanical Engineering (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Non-Flushing Toilets (AREA)
  • Accommodation For Nursing Or Treatment Tables (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne des exemples de barrières imperméables aux fluides de dispositifs de collecte de fluide et des procédés de formation d'une barrière imperméable aux fluides d'un dispositif de collecte de fluide. La barrière imperméable aux fluides comprend une surface interne définissant au moins partiellement une chambre, une première région d'extrémité définissant une ouverture s'étendant à travers celle-ci et comprenant une première partie de surface externe, et une seconde région d'extrémité distale par rapport à la première région d'extrémité et comprenant une seconde partie de surface externe ayant une force d'adhésion plus élevée que la première partie de surface externe. La barrière imperméable aux fluides définit également une ouverture s'étendant longitudinalement le long de la barrière imperméable aux fluides et configurée pour être positionnée adjacente à un urètre féminin.
PCT/US2020/033064 2019-06-21 2020-05-15 Dispositifs de collecte de fluide comprenant une zone de fixation de base, et systèmes et procédés associés Ceased WO2020256865A1 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
CA3143904A CA3143904C (fr) 2019-06-21 2020-05-15 Dispositifs de collecte de fluide comprenant une zone de fixation de base, et systemes et procedes associes
US17/596,629 US12419778B2 (en) 2019-06-21 2020-05-15 Fluid collection devices including a base securement area, and related systems and methods
EP20730518.6A EP3986344B1 (fr) 2019-06-21 2020-05-15 Dispositifs de collecte de fluide comprenant une zone de fixation de base, et systèmes et procédés associés
JP2021576074A JP7502347B2 (ja) 2019-06-21 2020-05-15 ベース固定領域を含む流体採取デバイス、ならびに関連するシステムおよび方法
CN202080057663.0A CN114502115B (zh) 2019-06-21 2020-05-15 包括基部固定区域的流体收集装置、以及相关的系统和方法
US19/310,118 US20260047956A1 (en) 2019-06-21 2025-08-26 Fluid collection devices including a base securement area, and related systems and methods

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962864656P 2019-06-21 2019-06-21
US62/864,656 2019-06-21

Related Child Applications (2)

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US17/596,629 A-371-Of-International US12419778B2 (en) 2019-06-21 2020-05-15 Fluid collection devices including a base securement area, and related systems and methods
US19/310,118 Continuation US20260047956A1 (en) 2019-06-21 2025-08-26 Fluid collection devices including a base securement area, and related systems and methods

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WO2020256865A1 true WO2020256865A1 (fr) 2020-12-24

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US (2) US12419778B2 (fr)
EP (1) EP3986344B1 (fr)
JP (1) JP7502347B2 (fr)
CN (1) CN114502115B (fr)
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WO (1) WO2020256865A1 (fr)

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US20260047956A1 (en) 2026-02-19
EP3986344A1 (fr) 2022-04-27
CA3143904A1 (fr) 2020-12-24
EP3986344B1 (fr) 2023-08-09
JP2022536986A (ja) 2022-08-22
CA3143904C (fr) 2023-11-28
US12419778B2 (en) 2025-09-23
US20220339024A1 (en) 2022-10-27
CN114502115A (zh) 2022-05-13
JP7502347B2 (ja) 2024-06-18

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